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Diss Factsheets
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EC number: 478-270-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-09-29 to 2007-05-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class method) without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate from the Department of Health of the Government of the United Kingdom
- Test type:
- acute toxic class method
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): VRT-753136 hcl
- Molecular formula: Not applicable
- Molecular weight: Not applicable
- Smiles notation: Not applicable
- InChl: Not applicable
- Structural formula attached as image file: Not applicable
- Substance type: No data
- Physical state: White powder
- Analytical purity: 100 area %
- Impurities: 0.03 area% of unknowns
- Composition of test material, percentage of components: No data
- Isomers composition: no data
- Purity test date: 2006-09-15
- Lot/batch No.: Batch number 25515/Lot No. AF6-001
- Expiration date of the lot/batch: 2008-05-01
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
- Other: No data
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Obtained from Charles River (UK) Ltd, Margate, Kent, England.
- Age at study initiation: The animals were approximately eight to twelve weeks of age prior to dosing.
- Weight at study initiation: 167 to 225 g
- Fasting period before study: The day prior to dosing (Day 1)
- Housing: The cages were made of a stainless steel body with a stainless steel mesh lid and floor, and were suspended above absorbent paper which was changed at appropriate intervals. The animals were housed in groups of three rats of the same sex.
- Diet: The animals were allowed free access to a standard rodent diet (Rat and Mouse No. 1 Maintenance Diet), except for overnight prior to and approximately four hours after dosing.
- Water: Potable water taken from the public supply was freely available via polycarbonate bottles fitted with sipper tubes.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23 deg C
- Humidity (%): 40 to 70%
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): Cycle of 12 hours continuous light and 12 hours continuous dark per 24 hours
IN-LIFE DATES:
- From: 2006-10-03 To: 2006-11-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: purified water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: The test substance was formulated at a concentration of 30 and 200 mg/mL in the vehicle.
- Amount of vehicle (if gavage): Administered at a volume of 10 mL/kg bodyweight.
- Justification for choice of vehicle: No data
- Lot/batch no.: No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED:
- No data
DOSAGE PREPARATION:
- The test substance formulations were prepared on the day of dosing. The absorption of the test substance was not determined.
CLASS METHOD
- Rationale for the selection of the starting dose: As results of the 300 mg/kg bodyweight dose level indicated the acute lethal oral dose of the test substance to be greater than 300 mg/kg bodyweight, in compliance with the study guidelines, a further two groups of three fasted female rats were similarly dosed at 2000 mg/kg to complete the study. - Doses:
- 300 and 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- Two groups of three female rats received a dose level of 300 mg/kg/bodyweight as well as two groups of three fasted female rats were similarly dosed at 2000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 – morning only). The nature and severity, where appropriate, of the clinical signs and the time they were observed were recorded at each observation.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, macropathology, other: mortality
Mortality:
Cages of rats were checked at least twice daily for any mortalities
Bodyweight:
The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
Macropathology:
All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- One female (F3) dosed at 300 mg/kg died on Day 3 and one female (F12) dosed at 2000 mg/kg died on Day 1 of treatment. There were no clinical signs noted prior to death. Macroscopic examination of the decedent treated at 300 mg/kg revealed congestion (characterised by darkened tissues/organs or blood vessels injected) of the subcutaneous tissue, brain, heart, lungs and liver; together with an enlarged/swollen/thickened heart, fluid contents of the duodenum, small intestine, and thoracic cavity, and a small caecum. Examination of the decedent treated at 2000 mg/kg revealed congestion (characterised by darkened tissues/organs or blood vessels injected) of the lungs and stomach and duodenum, and fluid contents in the stomach.
- Clinical signs:
- Clinical signs consisted of salivation noted immediately after dosing on Day 1 occurring in two females treated at 2000 mg/kg. This sign was resolvedby approximately 30 minutes after dosing. No other clinical signs were seen in any of the remaining animals dosed at 300 or 2000 mg/kg.
- Body weight:
- A bodyweight loss was recorded for one female (F11) dosed at 2000 mg/kg on Day 15. Low bodyweight gain was noted for one female (F8) on Day 15 dosed at 2000 mg/kg and two females (F1 and F4) on Day 15 dosed at 300 mg/kg. All other surviving animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- no data
- Other findings:
- - Macroscopic examination:
Macroscopic examination at study termination on Day 15 revealed white nodules in the large intestine of two females (F10 and F11) treated at 2000 mg/kg. Congestion (characterised by darkened tissues/organs) of the spleen was noted in one female (F1) treated at 300 mg/kg. No abnormalities were revealed in any other animal, at the macroscopic examination, at this time.
Any other information on results incl. tables
Not applicable
Applicant's summary and conclusion
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of VRT-753136 hcl was demonstrated to be greater than 2000 mg/kg bodyweight.
- Executive summary:
Not applicable
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